Diet and Exercise Program for Lymphoma Survivors

(LIFE-L Trial)

Overseen By Tracy E Crane, PhD, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Vegan, Ketogenic, Dementia, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a Mediterranean diet and a home-based exercise program can help lymphoma patients adhere to chemotherapy and reduce side effects. The trial includes two groups: one receives weekly coaching on diet and exercise, while the other receives materials and limited coaching later. It suits those with untreated Non-Hodgkin or Hodgkin lymphoma undergoing chemotherapy, who are not on a vegan or ketogenic diet, and who are not already highly active. Participants must have internet access and be open to trying a new diet and exercise routine. As an unphased trial, it provides a unique opportunity to explore lifestyle changes that may enhance treatment experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinators.

What prior data suggests that this diet and exercise program is safe for lymphoma survivors?

Research shows that both the LIFE-L Home-Based Exercise Program and the Mediterranean Diet are safe for people. An earlier study found that 86% of participants regularly attended exercise sessions, indicating they handled it well. Specifically, these participants experienced up to a 25% improvement in physical fitness and felt less tired.

Regarding the Mediterranean Diet, studies indicate that following it can lower the risk of death from any cause by 32% in cancer survivors. The diet may also help reduce inflammation and lower the chance of the disease returning.

Overall, previous research has shown positive results for both the exercise program and diet, making them well-tolerated options for lymphoma survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diet and Exercise Program for Lymphoma Survivors because it explores how lifestyle changes can support recovery alongside chemotherapy, which is the standard treatment. The program combines the LIFE-L Home-Based Exercise Program and the LIFE-L Mediterranean Diet, offering a fresh approach by integrating physical activity and nutrition into the treatment plan. This method is distinctive because it empowers patients to actively participate in their recovery at home, potentially enhancing their quality of life. Unlike traditional treatments, which focus solely on medication, this program emphasizes holistic health and could revolutionize how we support lymphoma survivors.

What evidence suggests that this diet and exercise program is effective for lymphoma survivors?

Research shows that following a Mediterranean diet and exercising can benefit people with lymphoma during chemotherapy. In this trial, participants in the LIFE-L Group will receive education on both a Mediterranean diet and an exercise program. Studies have found that cancer survivors who eat a Mediterranean diet have a 32% lower risk of dying from any cause. This diet, rich in fruits, vegetables, and healthy fats, is linked to better health for cancer survivors. Additionally, regular exercise can enhance physical abilities and reduce the side effects of cancer treatment. Overall, these lifestyle changes can help patients complete their chemotherapy and feel better during treatment. ^{1 2 5 6 7}

Who Is on the Research Team?

Craig Moskowitz, MD

Principal Investigator

University of Miami

Tracy E Crane, PhD, RDN

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 with untreated Non-Hodgkin or Hodgkin lymphoma, starting chemotherapy. Participants must understand English or Spanish, have internet access, and be willing to try a Mediterranean diet and exercise program. They can't already be very active or on special diets like vegan or ketogenic.

Inclusion Criteria

Approval from treating oncologist, confirmed via email or in writing

Able to provide consent

Able to read or understand English or Spanish

Exclusion Criteria

I have not had a stroke, heart attack, or heart failure in the last year.

Any contraindication for diet change or exercising as determined by physician

Currently following a vegan or ketogenic diet for the prior month

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants undergo 6 cycles of chemotherapy as per standard of care

Approximately 18 weeks

Weekly visits (in-person)

Lifestyle Intervention

Participants receive weekly phone sessions with a health coach for Mediterranean diet and exercise education

26 weeks

Weekly phone sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LIFE-L Home-Based Exercise Program
• LIFE-L Mediterranean Diet
• Supportive Materials

Trial Overview The study tests if a Mediterranean diet combined with a home-based exercise program helps Lymphoma patients handle chemo better and reduce side effects. Patients will either start this lifestyle intervention immediately or be placed in a waitlist group to compare outcomes.

How Is the Trial Designed?

Group I: LIFE-L Group Experimental Treatment 3 Interventions

Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.

Group II: Control Group Experimental Treatment 1 Intervention

Participants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

A systematic review of 58 publications identified 34 exercise programs for cancer survivors conducted in home or community settings, highlighting the diversity of interventions available.

The review revealed significant gaps in reporting on the implementation processes and contextual factors affecting these programs, indicating a need for more detailed studies to enhance future community-based exercise interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-Based Exercise Programs for Cancer Survivors: A Scoping Review of Program Characteristics Using the Consolidated Framework for Implementation Research. Neil-Sztramko, SE., Smith-Turchyn, J., Fong, A., et al.[2022]

Nutrition and lifestyle advice are crucial for cancer survivors to improve their quality of life and potentially reduce the risk of cancer recurrence, highlighting the role of frontline nurses in providing this support.

There is a need for enhanced education and interprofessional collaboration among healthcare providers to ensure consistent and effective nutritional guidance for cancer survivors, as well as more research to determine the best training methods for nurses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of nutrition, diet and lifestyle advice for cancer survivors - the role of nursing staff and interprofessional workers. Murphy, JL., Girot, EA.[2016]

A 6-month dietary intervention for breast cancer survivors significantly improved adherence to a Mediterranean-style diet, with the intervention group increasing their adherence by 22.5% compared to only 2.7% in the control group.

The intervention led to a notable increase in the consumption of anti-inflammatory foods, herbs, and spices, particularly cinnamon, turmeric, and garlic, while also reducing the intake of red meat and sweets, suggesting a positive shift towards healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intervention among breast cancer survivors increased adherence to a Mediterranean-style, anti-inflammatory dietary pattern: the Rx for Better Breast Health Randomized Controlled Trial. Zuniga, KE., Parma, DL., Muñoz, E., et al.[2020]

A 3-month lifestyle intervention focusing on diet and exercise significantly improved cardiometabolic health markers in 30 breast cancer survivors, including reductions in body mass index, waist circumference, and improvements in cardiorespiratory fitness (V˙O2max) and adherence to the Mediterranean diet.

The positive effects on diet adherence and V˙O2max were maintained for up to 24 months, indicating long-term benefits of the intervention, while some improvements in insulin resistance and triglycerides were observed for up to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a lifestyle intervention program's on breast cancer survivors' cardiometabolic health: Two-year follow-up. Natalucci, V., Ferri Marini, C., Lucertini, F., et al.[2023]

The Med-Food Anticancer Program (MFAP) aims to promote the Mediterranean diet and physical activity among adults to help prevent cancer, focusing on increasing the intake of healthy foods like legumes, fish, and vegetables while reducing meat and dairy consumption.

Two studies have demonstrated the effectiveness of the MFAP in achieving its dietary and physical activity goals, suggesting that structured public health programs can successfully encourage healthier lifestyles to combat cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition prevention intervention for cancers: "Med-Food Anticancer Program"]. Panunzio, MF., Caporizzi, R., Antoniciello, A., et al.[2012]

A 3-month home-based lifestyle intervention focusing on nutrition and exercise significantly improved cardiometabolic health in 30 breast cancer survivors, including reductions in body mass index and insulin resistance.

Participants showed enhanced physical activity levels and cardiorespiratory fitness, along with improvements in heart function and inflammatory markers, demonstrating the efficacy of lifestyle changes even during COVID-19 lockdowns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Home-Based Lifestyle Intervention Program on Cardiometabolic Health in Breast Cancer Survivors during the COVID-19 Lockdown. Natalucci, V., Marini, CF., Flori, M., et al.[2021]

In a review of 24 adult studies, strong evidence indicates that exercise interventions significantly improve body composition in hematological cancer survivors, while there is promising but weaker evidence for benefits in cardiorespiratory fitness, fatigue, muscle strength, physical functioning, and quality of life.

For pediatric survivors, 13 studies showed strong evidence that exercise, especially in hospital settings, enhances muscle strength and cardiorespiratory fitness, with no exercise-related risks identified for either adults or children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in adult and pediatric hematological cancer survivors: an intervention review. Wolin, KY., Ruiz, JR., Tuchman, H., et al.[2013]

High adherence to the Mediterranean diet (MD) is associated with a significant reduction in all-cause mortality (hazard ratio 0.78) and non-breast-cancer mortality (hazard ratio 0.67) among female breast cancer survivors, based on a systematic review of 11 studies.

The impact of the MD on quality of life and other health-related outcomes was inconsistent, indicating that while the diet may improve survival rates, more research is needed to understand its broader health benefits for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of the Mediterranean Diet in Breast Cancer Survivorship: A Systematic Review and Meta-Analysis of Observational Studies and Randomised Controlled Trials. Chen, G., Leary, S., Niu, J., et al.[2023]

A 12-month lifestyle modification program, including a Mediterranean diet, exercise, and vitamin D supplementation, significantly improved health-related quality of life (HRQoL) in 227 breast cancer survivors, with notable increases in global health status and reductions in fatigue and other symptoms.

The study suggests that maintaining a healthy lifestyle can enhance HRQoL by potentially reducing body weight and improving vitamin D levels, which may alleviate breast cancer-related symptoms and positively influence treatment compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Life in Women Diagnosed with Breast Cancer after a 12-Month Treatment of Lifestyle Modifications. Montagnese, C., Porciello, G., Vitale, S., et al.[2021]

The German version of the Mediterranean Diet Adherence Screener (MEDAS) was validated in a study involving 68 women with BRCA1/2 mutations, showing high concordance with a full-length Food Frequency Questionnaire, indicating its reliability for assessing adherence to the Mediterranean Diet.

Participants who adhered more closely to the Mediterranean Diet, as measured by MEDAS, demonstrated significant associations with beneficial dietary biomarkers, such as higher omega-3 and lower omega-6 fatty acid levels, suggesting potential health benefits from the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. Hebestreit, K., Yahiaoui-Doktor, M., Engel, C., et al.[2019]

Incorporating lifestyle changes, such as diet and physical activity, during and after cancer treatment can significantly improve patients' quality of life and reduce the risk of sarcopenia, which is the loss of muscle mass and strength.

Specifically, a combination of physical activity and the APA-diet can lower the risk of cancer relapse in remission, especially for overweight patients, highlighting the importance of personalized interventions by trained professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. Gouez, M., Raynard, B., Marijnen, P., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05839210

Lifestyle Intervention of Food and Exercise for Lymphoma ... The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03741

Lifestyle Intervention of Food and Exercise for Lymphoma ... This clinical trial assesses the impact of a guided nutrition and exercise program (LIFE) in alleviating the side effects of chemotherapy in patients with ...

3. umiamihealth.org umiamihealth.org/en/sylvester-comprehensive-cancer-center/impact-reports/2022/driving-research-for-patients/the-lifestyle-intervention-of-food-and-exercise-for-lymphoma-%E2%80%93-the-life-l-study

The Lifestyle Intervention Of Food And Exercise For ... In 2022, we opened the Lifestyle Intervention of Food and Exercise for Lymphoma — or the LIFE-L Study to better understand the potential impact of lifestyle ...

4. researchgate.net researchgate.net/publication/372469403_Lifestyle_Intervention_of_Food_and_Exercise_for_Lymphoma_Survivors_LIFE_-L

Lifestyle Intervention of Food and Exercise for Lymphoma ... Positive results have been observed for a diverse set of outcomes, including physiologic measures, objective performance indicators, self-reported functioning ...

5. news.med.miami.edu news.med.miami.edu/nutrition-exercise-and-cancer-outcomes/

The Impact of Nutrition and Exercise on Cancer Outcomes “The LIFE-L study is among the first to test a lifestyle intervention during treatment for lymphoma,” said Dr. Moskowitz, physician-in-chief at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9280599/

Evidence-based exercises intervention in adults diagnosed ... 86% patients showed up in average of 10 sessions of supervised exercise in IG. Result showed up to 25% improvement in physical fitness. Fatigue level was ...

7. umiamihealth.org umiamihealth.org/en/sylvester-comprehensive-cancer-center/research/labs/crane-lab/research

Research This study is anticipated to open in 2024. Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE-L) (NCT05839210): This pilot randomized, ...